Actively Recruiting

Phase 1
Phase 2
Age: 18Years +
All Genders
NCT05875168

First-in-Human Study of DS-3939a in Participants With Advanced Solid Tumors

Led by Daiichi Sankyo · Updated on 2026-04-20

540

Participants Needed

33

Research Sites

182 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This study will evaluate the safety, tolerability, and efficacy of DS-3939a in participants with advanced solid tumors.

CONDITIONS

Official Title

First-in-Human Study of DS-3939a in Participants With Advanced Solid Tumors

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Signed and dated the main Informed Consent Form (ICF)
  • Left ventricular ejection fraction 50% or higher within 28 days before enrollment
  • Adequate organ function
  • Measurable disease based on RECIST V1.1
  • Eastern Cooperative Oncology Group performance status of 0 or 1
  • Histologically or cytologically confirmed locally advanced, metastatic, or unresectable solid malignant tumors (Part 1)
  • Histologically or cytologically confirmed locally advanced, metastatic, or unresectable cancer with documented disease progression after recent anticancer therapy (Part 2)
  • Ability to provide baseline tumor samples through fresh biopsy or recent archived tissue samples obtained within 6 months before signing ICF (Part 2)
Not Eligible

You will not qualify if you...

  • Prior treatment targeting mucin 1 (MUC1) or TA-MUC1
  • Spinal cord compression or active central nervous system metastases
  • Multiple primary malignancies except certain treated skin or in situ cancers with no disease evidence for 3 or more years
  • History or current noninfectious interstitial lung disease (ILD)/pneumonitis or suspected ILD/pneumonitis not ruled out by imaging
  • Active or uncontrolled HIV infection
  • Active or uncontrolled hepatitis B or C infection
  • Cerebrovascular accident, transient ischemic attack, or arterial thromboembolic event within past 6 months
  • Active, known, or suspected autoimmune disease
  • Current participation in other therapeutic investigational procedures except for Long Term Follow-Up without investigational treatment

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 33 locations

1

Florida Cancer Specialists

Sarasota, Florida, United States, 34232

Actively Recruiting

2

Oregon Health & Science University

Portland, Oregon, United States, 97239

Actively Recruiting

3

Rhode Island Hospital

Providence, Rhode Island, United States, 02903

Actively Recruiting

4

University of Texas M.D. Anderson Cancer Center

Houston, Texas, United States, 77030

Actively Recruiting

5

Huntsman Cancer Institute, University of Utah

Salt Lake City, Utah, United States, 84112

Actively Recruiting

6

The Medical College of Wisconsin, INC

Milwaukee, Wisconsin, United States, 53226

Actively Recruiting

7

UZ Leuven

Leuven, Belgium, 3000

Actively Recruiting

8

McGill University Health Center

Montreal, Canada, H4A 3J1

Not Yet Recruiting

9

Princess Margaret Cancer Center

Toronto, Canada, M5G2M9

Actively Recruiting

10

Beijing Cancer Hospital

Beijing, China, 100142

Not Yet Recruiting

11

Shandong Cancer Hospital

Jinan, China, 250117

Actively Recruiting

12

The Second Peoples Hospital of Neijiang

Neijiang, China, 641000

Actively Recruiting

13

Shanghai East Hospital

Shanghai, China, 200120

Actively Recruiting

14

Centre Léon Bérard

Lyon, France, 69008

Actively Recruiting

15

Assistance Publique- de Marseille

Marseille, France, 13005

Actively Recruiting

16

Chu Strasbourg

Strasbourg, France, 67091

Actively Recruiting

17

Institut Claudius Regaud

Toulouse, France, 31059

Actively Recruiting

18

Institut Gustave Roussy

Villejuif, France, 94805

Actively Recruiting

19

National Cancer Center Hospital

Chūōku, Japan, 104-0045

Actively Recruiting

20

Kansai Medical University Hospital

Hirakata-shi, Japan, 573-1191

Actively Recruiting

21

National Cancer Center Hospital East

Kashiwa, Japan, 277-8577

Actively Recruiting

22

Cancer Institute Hospital of Jfcr

Kōtoku, Japan, 135-8550

Actively Recruiting

23

Kindai University Hospital

Ōsaka-sayama, Japan, 589-8511

Actively Recruiting

24

Seoul National University Hospital

Seoul, South Korea, 03080

Actively Recruiting

25

Severance Hospital, Yonsei University Health System

Seoul, South Korea, 03722

Actively Recruiting

26

Asan Medical Center

Seoul, South Korea, 05505

Actively Recruiting

27

Samsung Medical Center

Seoul, South Korea, 06351

Actively Recruiting

28

Hospital Universitari Vall D'Hebron

Barcelona, Spain, 8035

Actively Recruiting

29

Hospital Universitario Ramon Y Cajal

Madrid, Spain, 28034

Actively Recruiting

30

Hospital Universitario La Paz

Madrid, Spain, 28046

Actively Recruiting

31

Hospital Regional Universitario de Malaga

Málaga, Spain, 29010

Actively Recruiting

32

Next Madrid

Pozuelo de Alarcón, Spain, 28223

Actively Recruiting

33

Hospital Universitario Virgen Macarena

Seville, Spain, 41009

Actively Recruiting

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Research Team

(

(US Sites) Daiichi Sankyo Contact for Clinical Trial Information

CONTACT

(

(Asia Sites) Daiichi Sankyo Contact for Clinical Trial Information

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

2

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First-in-Human Study of DS-3939a in Participants With Advanced Solid Tumors | DecenTrialz